A Phase 4 interventional study of 1,25 (OH)2 D3 and Inspiratory isometric resistance training in Cancer, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-26.
Sponsored by Mayo Clinic · Phase 4, Interventional, and Supportive care
This research is intended to begin to explore the impact of inspiratory muscle resistance exercise and/or 1,25(OH)2D3 for improving respiratory muscle strength in cancer patients (subjects).
Exclusion Criteria:
Inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus oral placebo for eight weeks
Other: Inspiratory isometric resistance training · Drug: Oral Placebo · Device: Threshold Inspiratory Muscle Trainer (IMT)
Sham inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus 1,25 (OH)2 D3 orally for eight weeks
Drug: 1,25 (OH)2 D3 · Other: Sham Inspiratory Isometric Resistance Training · Device: Threshold Inspiratory Muscle Trainer (IMT)
Inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus 1,25(OH)2 D3 orally for eight weeks
Drug: 1,25 (OH)2 D3 · Other: Inspiratory isometric resistance training · Device: Threshold Inspiratory Muscle Trainer (IMT)
Sham inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus oral placebo orally for eight weeks
Drug: Oral Placebo · Other: Sham Inspiratory Isometric Resistance Training · Device: Threshold Inspiratory Muscle Trainer (IMT)
0.25 micrograms, taken daily for eight weeks, orally
Also known as: Calcitriol, 1, 25-dihydroxycholecalciferol, Rocaltrol
A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles.Participants in the active groups will breathe against a resistance set to generate 30% of maximal inspiratory pressure (PImax).
Placebo will be created to mimic the appearance of the study drug
A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles. Participants in the sham group will train daily against a resistance set to only 15% PImax.
A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles.
Also known as: Threshold IMT Breathing Trainer
Sniff Nasal Inspiratory Pressure (SNIP)
SNIP is a test of maximal inspiratory muscle force exerting from the diaphram. Patients sniff forcefully through one nostril while the other is obstructed. The best of 10 measurements is recorded.
Time frame: 8 weeks
A study coordinator worked closely with Dr. Jatoi in numerous clinics in the Division of Medical Oncology to identify potential candidates for this study.
| Milestone | Training and Placebo | Sham Training and Vitamin D3 Metabolite | Training and Vitamin D3 Metabolite | Sham Training and Placebo |
|---|---|---|---|---|
| Started | 16 | 15 | 15 | 17 |
| Completed | 14 | 15 | 15 | 16 |
| Not completed | 2 | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 2 | 0 | 0 | 1 |
SNIP is a test of maximal inspiratory muscle force exerting from the diaphram. Patients sniff forcefully through one nostril while the other is obstructed. The best of 10 measurements is recorded.
| cmH20 | Training and Placebo | Sham Training and Vitamin D3 Metabolite | Training and Vitamin D3 Metabolite | Sham Training and Placebo |
|---|---|---|---|---|
| Sniff Nasal Inspiratory Pressure (SNIP) | 90 (51 to 190) | 87 (51 to 159) | 89 (43 to 150) | 109 (74 to 153) |
Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Training and Placebo | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Sham Training and Vitamin D3 Metabolite | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Training and Vitamin D3 Metabolite | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Sham Training and Placebo | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| Age, Categorical(Participants) | Training and Placebo | Sham Training and Vitamin D3 Metabolite | Training and Vitamin D3 Metabolite | Sham Training and Placebo | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 13 | 12 | 11 | 15 | 51 |
| >=65 years | 3 | 3 | 4 | 2 | 12 |
| Age, Continuous(years) | Training and Placebo | Sham Training and Vitamin D3 Metabolite | Training and Vitamin D3 Metabolite | Sham Training and Placebo | Total |
|---|---|---|---|---|---|
| Mean | 52.5 (34 to 72) | 58 (42 to 81) | 55 (31 to 74) | 51 (26 to 75) | 54 (26 to 81) |
| Sex: Female, Male(Participants) | Training and Placebo | Sham Training and Vitamin D3 Metabolite | Training and Vitamin D3 Metabolite | Sham Training and Placebo | Total |
|---|---|---|---|---|---|
| Female | 13 | 12 | 13 | 12 | 50 |
| Male | 3 | 3 | 2 | 5 | 13 |
| Race/Ethnicity, Customized(Participants) | Training and Placebo | Sham Training and Vitamin D3 Metabolite | Training and Vitamin D3 Metabolite | Sham Training and Placebo | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Training and Placebo | Sham Training and Vitamin D3 Metabolite | Training and Vitamin D3 Metabolite | Sham Training and Placebo | Total |
|---|---|---|---|---|---|
| United States | 14 | 15 | 15 | 16 | 60 |
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